PDT treatment method for cellulites and cosmetic use

ABSTRACT

A photosensitizer mixture and a method of treating cellulites by means of a percutaneous application of the mixture into the area of cellulite buildup followed by light illumination are presented. The photosensitizer can be combined with one or more cellular products including adipose cells and/or collagen that have been previously removed by liposuction. This mixture can also include other compounds such as Lipofundin MCT 10% to improve the photosensitizer&#39;s diffusion or to dilute it Varying concentrations are used depending on the area of treatment as well as the stage of the cellulites and whether the cellulites present a depressed area in the skin or an elevated area. The cosmetic treatment method substantially reduces or removes localized lipodystrophies and/or flaccidity and/or cellulite by localized laser, LED or other light irradiation of the area of treatment having a photosensitizer applied therein. The light energy is applied to destroy the “fat” cells by a combination of chemical reactions, primarily, and temperature wherein the cell walls break releasing the cell fluid. The light radiation is generally applied through devices to guide the radiation to the area of treatment. One or more light sources such as laser diodes or LEDs may be coupled into one or more optical fibers to increase the area of coverage as well as increase the amount of radiation in that area of coverage. Optical fibers can be introduced percutaneously or possibly interstitially into the area of treatment. Cell fluid in the area of treatment is removed by a combination of techniques. Quick and lasting cosmetic changes in areas having prior untreatable cellulite fat tissues are achieved while minimizing trauma.

DOMESTIC PRIORITY UNDER 35 USC 119(e)

This application claims the benefit of U.S. Provisional Application Ser.No. 60/704,797, filed Aug. 2, 2005, which is incorporated by referenceherein.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention relates to the field of cosmetic treatment and, inparticular, relates to a photodynamic therapy treatment to removecellulite tissue and also excess adipose cells in areas of the bodyprone to buildup of such tissues.

2. Invention Disclosure Statement

It is a well known fact that modern society has created an abundance ofreadily available foods, i.e., “fast foods,” and also has created anenvironment where entertainment has fostered a sedentary life style of,for example, watching television, playing video games and talking on thephone while eating high caloric snack foods. This has allowed people togain excessive weight by an increase in adipose tissue, fat cells.Certain heredity conditions further have also created areas of excessivefat cells that are difficult to remove in that they are in areas thatare not affected or minimally affected by diet and exercise. In an areawhere fat cells have excessively accumulated, normally in the buttocks,hips, and thighs, especially in women, the collagen fibers are deformedwhich allows pockets of fat cells to build up and deform the skinsurface into producing bubbles or ripples, also called cellulite.

“Edematous-fibrosclerotic panniculopathy” is a medical term used todescribe cellulite. Cellulite affects 80-90% of women in theirpost-pubertal period. Cellulites are found commonly on the hips, thighs,and buttocks giving a dimpled appearance in those areas of the body. Itis not a disorder but an issue of cosmetic concern to the individual.Cellulite is most often seen in women than in men due to the structuraldifferences of their adipose tissue. Cellulite is not related to obesityor overweight, since it can occur even in normal and thin women.

Cellulite is different from fat cell layer in the body. Most fattydeposit in the individual depends on his/her weight, life style andgenetic makeup. Fat layer in the body had important function ofinsulation, protecting vital organs etc. while cellulite is largely dueto structural conformation below the skin which appears as lumpy pocketsof trapped fat giving uneven dimpling or orange peel skin.

Cellulite develops in the hypodermis or subcutaneous fat layer, wherefat lobes are organized into chambers by surrounding strands ofconnective tissue. Below this layer is scarpus fascia in which fat cellsget larger when weight is gained. This layer is divided into chambers byconnective tissue, which attaches the top layer of the skin to the lowerlayers of muscle. When these connective tissues become weak, the scarpusfascia bulges upward, causing the characteristic uneven, dimpledappearance in the skin.

Most procedures are ineffective in removing cellulite except for a longterm dieting and exercise. The development of cellulite is geneticallydriven and is considered a normal condition and is thus difficult toremove.

Excessive fat depositions or “lipodystrophies” are produced by adisproportionate increase in the deeper section of the subcutaneouscellular tissues of fat cells.

Lipodystrophies are produced because the adiposities have a hereditarygenetic code which makes them evolve in a specific way. Each adipocitecell has Beta 1 (lipogenetic) and Alfa 2 (lipolitic) receptors in itsmembrane. When there are more Beta 1 receptors on a particular area,then a localized obesity or lipodystrophy is produced. Because of theexcessive Beta receptors in certain families, these families have atendency for enlarged legs, breasts, waists, etc. On these patientstreatment with low caloric diets exclusively is normally not successfulwhich leads to abandonment of the treatment and recovering whateverlocalized fat was removed and returning to the same unhealthfulpractices.

The only effective way to treat cellulite is to directly act on thegenetically altered fat tissues and similar tissues in the area oftreatment.

Historically, different methods have been developed to treat thisproblem and billions of dollars are being spent annually by people toremove or reduce fat tissue in these areas of the body. By the late 70'sliposuction started to be used followed by liposculpture in the late80's being an improved liposuction performed under local anesthesiausing traumatic trocars to remove fluids. Later ultrasonic liposculpturewas developed by mid 90's and there are some reports on “laserliposuction” (using an external laser source) but laser assistedliposuction has not been clearly proved to be effective so far.

Among the patents covering the state of the light are the following.

U.S. Pat. No. 6,206,873 by Paolini, et al., titled, “Device and Methodfor Eliminating Adipose Layers by Means of Laser Energy,” discloses ahollow needle with an optical fiber in the center. The fat tissue,adipose cells, is liquidized when the cell walls are broken. The fluidis removed by suction through the needle. The laser is used to simplythermally degrade the cell walls. Laser wavelength range is noted asfrom 0.75 to 2.5 microns but a preferred wavelength of 1.06 is calledout. A rounded optical fiber end is shown in FIG. 3 beyond the needleend. Paolini et al. use a Nd:YAG type of laser and note a wavelengthrange above. Paolini et al. further note that the liquid produced may beremoved from the body by normal absorption.

While in U.S. Pat. No. 6,605,080 Altshuler et al. disclose the removalof lipid rich tissue using external laser, a YAG source as well as otherlasers whose output energy are in a wavelength range of 880 to 935 nm,1150 to 1230 nm or 2280 to 2360 nm. It is noted that the radiation inthe lower bands, specifically, 900 to 930, and 1150 to 1230, arepreferred in the treatment of fat tissue. Specifically, wavelengthregions near water/OH absorptions are identified as not preferred. Alsothey recommend the use of a cooling system.

U.S. Pat. No. 6,743,215 by Bernakei, titled, “Method and Apparatus forSkin Absorption Enhancement and Cellulite Reduction” discloses a processincluding the application of a compound upon an abraded skin surfacefollowed by electrical and mechanical to remove cellulite.

Publication WO 99/48474 by A. Casale, entitled, “Pharmaceutical orCosmetic Compositions Containing Photosensitizer Substances,” disclosesa photosensitizer formulation of liposomes with the PS activated by alight of the wavelength between 700 and 900 nm. While the invention isbasically about an effective formulation of photosensitizer agent foruse in pharmaceutics and cosmetic applications, photosensitizers orprecursors with activation bands away from.

Most of the prior art methods mentioned above are useful for fatreduction (over weight or obesity), while cellulite is a differentcondition related to fat cells which cannot be addressed effectivelyusing the above methods. Presently there is no truly effective treatmentfor cellulite.

There is thus a need for treatment techniques that minimizes surfacedistortion, post operative complications, and removes or reducescellulite problem from selected areas. The present invention satisfiesthat need.

OBJECTIVES AND BRIEF SUMMARY OF THE INVENTION

It is an objective of the present invention to provide a method ofcosmetic treatment using laser, LED or other (e.g. a filtered lamp)radiation in conjunction with a photo-drug for the destruction ofcellulite tissue in the area of treatment.

It is another objective of the present invention to provide a method ofcosmetic treatment using radiation and a photo-drug that directlyaffects the sub-dermal fatty tissues.

It is yet another objective of the present invention to provide a methodof cosmetic treatment using PhotoDynamic Therapy (PDT) to directlyaffect adiposites causing emulsification of the fatty tissue and thenelimination by absorption, removal by the lymphatic system and bydrainage.

It is still another objective of the present invention to provide amethod of cosmetic treatment using PDT to directly affect the fattytissues without destruction of the structural tissues.

It is a further objective of the present invention to provide aphotosensitizer mixture to be used in a method of cosmetic treatmentusing PDT to reduce cellulites.

Briefly stated, the present invention provides a photosensitizer mixtureand a method of treating cellulites by means of a percutaneousapplication of the mixture into the area of cellulite buildup followedby light illumination is presented. The photosensitizer can be combinedwith one or more cellular products including adipose cells and/orcollagen or hyaluronic acid or compounds that have been previouslyremoved by liposuction. This mixture can also include other compoundssuch as Lipofundin MCT 10% to improve the photosensitizer's diffusion orto dilute it Varying concentrations are used depending on the area oftreatment as well as the stage of the cellulites and whether thecellulites present a depressed area in the skin or an elevated area. Thecosmetic treatment method substantially reduces or removes localizedlipodystrophies and/or flaccidity and/or cellulite by localized laser,LED or other light irradiation of the area of treatment having aphotosensitizer applied therein. The light energy is applied to destroythe “fat” cells by a combination of chemical reactions, primarily, andtemperature wherein the cell walls break releasing the cell fluid. Thelight radiation is generally applied through devices to guide theradiation to the area of treatment. One or more light sources such aslaser diodes or LEDs may be coupled into one or more optical fibers toincrease the area of coverage as well as increase the amount ofradiation in that area of coverage. Optical fibers can be introducedpercutaneously or possibly interstitially into the area of treatment.Cell fluid in the area of treatment is removed by a combination oftechniques. Quick and lasting cosmetic changes in areas having prioruntreatable cellulite fat tissues are achieved while minimizing trauma.

The above, and other objects, features and advantages of the presentinvention will become apparent from the following description read inconjunction with the accompanying drawings.

BRIEF DESCRIPTION OF FIGURES

FIGS. 1A and 1B illustrate the before and after treatment of a hip areawithin days after treatment of a first patient by the method/compositionof the present invention;

FIGS. 2A and 2B illustrate the before and after treatment of a lowerbuttock area within days after treatment of said first patient by themethod/composition of the present invention;

FIGS. 3A and 3B illustrate the before and after treatment of a thigharea within days after treatment of said first patient by the presentinvention;

FIGS. 4A, and 4B illustrate a second patient having cellulites intypical areas of the body;

FIGS. 5A and 5B illustrate the second patient, after having treatment bythe present invention, showing the absence of cellulites in these sametypical areas.

FIG. 6 illustrate a third patient before treatment and then 1 month and6 months after treatment by the method and composition of the presentinvention;

FIG. 7 illustrates the process of Temoporfin interacting with cells.

FIG. 8 illustrates the chemical makeup of Temoporfin.

FIGS. 9A and 9B illustrate appropriate marking of sectors havingcellulite thereon.

FIG. 10 to 16 presents before and after pictures, of varying days, of 8female patients, ranging in age from 23 to 56 years initially havingStage II, III or IV cellulites which pictorially demonstrates thesuccess of the present invention in reducing the stage of cellulites ineach patient;

DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS

Many women suffer, have suffered or are going to be at some timeafflicted with cellulites in their life. It is an esthetic pathologythat only has pathological general connotations.

It is a problem that belongs to mostly women, in general, and normallywomen older than 20 years.

The appearance of cellulites is a psychologically depressing event tomany women because it appears in body areas that are exposed whenwearing bathing suits, for example. The skin has a bubbly appearancewith depressions and hills. Millions of dollars are spent by womenseeking a cure each year for numerous advertised remedies by thecosmetology industry. Many of these remedies do not provide any longterm solutions but only temporary relief by the elimination of excesswater from cellular tissues.

There is not an adequate definitive solution, just medical andcosmetologic treatments that generally do not achieve the patient'scomplete satisfaction.

The goals of the present invention in regards to the treatment ofcellulites is to: (1) provide a method of esthetic alterations of theskin for improving its visual aspect; (2) provide a process forhomeostasis of the cells that are altered in the treatment ofcellulites; and (3) increase of the web of collagen for optimizing theresults of the adipose graft when treating cellulites.

In the present invention, suitable photosensitizers porphyrins and theirderivatives, including temoporfin, chlorins, bacteriopheophorbide,bacteriochlorins etc are used. The selected photosensitizer can beadministered using suitable delivery systems like liposomes, prodrug etcfor efficient drug delivery to selected target cell. As commonly usedthroughout this specification and claims ‘photosensitizer’ is used toinclude precursors of photosensitizers, which naturally becomephotosensitizers after introduction into a patient as the precursor.

The series of photographs, FIG. 1 to 6, present dramatic evidence of thesuccess of the present invention in substantially reducing the effectsand appearance of cellulites in three patients after only 1 or severaltreatments and only a few days after the treatments.

When the photosensitizer Temoporfin is activated with light from a diodelaser, e.g., 652 nm wavelength, this produces an intracellular oxidationthat is believed to act to modify the cell membrane's properties, thecytoplasm, ribosomas, Golgi's appliance, and nucleus, eventuallytriggering a series of events that result with the cell apostosis.

The cell when exposed to the effects of Temoporfin or otherphotosensitizer begins a series of morphologic changes. The plasmamembrane alters and the characteristic blebbing appears. The cell volumedecreases considerably and the cytoplasm condenses. The nucleus becomessmaller and chromatin become denser and eventually collapses splittinginto several spheres of material.

At the end of apostosis, the cell is ingested by phagocytosis or bynearby cells avoiding the inflammatory response typical during normalcell necrosis. Even though the cell disappears, there is an increase ofthe collagen web. This improves the support of collagen, realignment ofthe collagen fibers and elastin, decreases the gelatinous consistency ofthe fundamental inter-cell substance, improves oxygenation and cellnutrition, and decreases toxic metabolites' retention and the edema.

Temoporfin is a very efficient generator of active oxygen which does notrequire a large dose of the drug nor a long exposure to light.

FIG. 7 illustrates the process of Temoporfin's interaction uponactivation.

The intracellular oxidation is responsible for the alterations of themembrane's surface and the nuclear, the mitocondrias, Golgi's appliance,the net endoplasmatic and the ribosomas resulting in the death of thecells or cell apoptosis.

Temoporfin in the past has been used in the treatment of some head andneck cancers.

Temoporfin is totally innocuous and inactive in the dark and isactivated with low intensities of light and it turns into a powerfulisolated-oxygen generator.

EXAMPLE 1

A patient having cellulites is treated with Temoporfin in severalsessions.

The variables in this treatment program are as follows:

-   1.—A determination of the grade of cellulites in the patient.-   2.—A determination of the dose and concentration of Temoporfin and    to confirm that it produces an improvement on the cellulites, and to    further insure that it is possible to apply it directly by    Mesotherapy without the need of systemic introduction.-   3.—A determination as to the potency of Temoporfin based on the time    of application to the time of laser application; and-   4.—A determination as to accompanying treatments.

The dilutions used for treatment are presented in the following Table 1:TABLE 1 CONCEN- PURE PHYSIOLOGICAL TRATION PRODUCT TEMOPORFIN SERUMmg/ml 5 gr. 7.5 mg  5 ml 1.5 mg/ml 5 gr. 7.5 mg 25 ml 0.3 mg/ml 5 gr.7.5 mg 37.5 ml   0.2 mg/ml 5 gr 7.5 mg 50 ml 0.15 mg/ml  5 gr 7.5 mg 75ml 0.1 mg/ml

To treat cellulites a concentration of 0.005 mg/ml is applied directlyby Mesotherapy. This concentration results from the study of optimalconcentrations for the use of m-THPC on the treatment of tumors: 0.1 to0.3 micrograms per gram of tumor tissue. The aesthetic doses are 10times lower as the objective is to develop a collagen matrix and notdestroy a tumor. Therefore, the aesthetic doses range from 5 to 15 μg/50gr of cellulites tissues.

To apply Mesotherapy on 50 gr of tissue, 2 cc of solution is applied(area of 100 cm² with a diffusion of 0.5 cm depth).

Finally, 2 cc of Mesotherapy solution must contain 0.005 to 0.015 mg ofm-THPC so its concentration must be as follows: Concentration of M-THPCfor Mesotherapy on cellulites: 0.005 mg/ml to 0.01 mg/ml.

General Procedure:

In order to determine the stage as well as the location of thecellulites in the patient, CONTACT THERMOGRAPHY may be used.

High Resolution Contact Thermography is ideal to accomplishclassification of the grade of cellulites and patient tracking duringtreatment since small variations are evidenced during treatment.

This process measures the superficial temperature of the skin surfacewhen placed in contact therewith by means of a plate of capsulatedliquid crystals. The color of the crystals is an indication of thetemperature of the underlying skin. Several plates are available havingdifferent temperature ranges appropriate for skin application. Two ofthese plates are shown below:

The brown colors mark hypothermic zones with little circulation and theblue colors indicate hypothermic zones with increased circulation. Thetemperatures are registered on the skin and provide 3 or 4 grades oftemperatures of the hypodermis. The homogeneous imagery indicates thecondition of the cellulites and provides exactness of diagnosis,topography and the cellulites stage. The following are examples ofimagery from cellulites areas as well as the stages associated with thatcellulites:

This is a uniform, unstained color image that is obtained at sectorswith absence of cellulites. A reference termography may be done on thearm or on the forearm zones that in general do not present cellulites.

Evolutionary grades or cellulites stages used in the treatment ofpatients:

The following conditions are indicative of Stages I and II: Slowing downof the venous and lymphatic circulation; with the dilatation of thelittle veins of the deep cape of the dermis. Interstitial edema at zonessurround the adipose cells. The exudation increases rapidly for theserum from the capillaries of the subcutaneous tissue. The zone withedema compresses the conjunctive fibers as well as the nervous elements,and it can manifest itself with pain by touch and at times spontaneous.There may be alterations of sensibility and formation of stretch marks.

There is histology of hyperplatia and hypertrophy of the reticularfibers that surround the adipose cells and the capillaries. These phasesare reversible.

Thermography in these stages presents hyperthermic big and diffuseborders, surrounded stains evidence hypodermic diffuse zones and theimage translates the alteration and instability of the microcirculationof the zone.

In Stage III, there is fibrous proliferation. The fibers swell up andthere is a decrease of collagen, an increase in the fibrin and loss ofthe individual characteristics of little fibers that mask a namedfibrinoide type. Collagen is deconstructed and degenerated, formingirregular, amorphous blocks, losing its structure and provokingconfinement of the full adipositos of tri-glycerides. The clinical andvisual aspect is termed the “orange skin.” There is slowing down of cellvascular interchanges thus forming micronodules. The reversibility ofthe effect becomes more difficult in this phase.

Thermography evidence: The image is a multi-colored image where thepredominate colors are celestial green and pink. Leopard's aspect of theskin localizes the irregularities of temperature in the skin for effectof the micronodules. The very cold zones that the black announces beginto appear as “Black Holes” which characterize stage IV cellulite.

SKIN OF LEOPARD or MICRONODULES or STAGE III (III)

Stage IV: The fibrosis increases and compresses veins and nervesproducing an alteration of the elements of the conjunctive tissue. Theadipose tissue is divided into compartments like tablets with largehypothermic blocks because of its low sanguine circulation. Theadipocytes are normal, but they are compressed. Several contiguousintervening micronodules fuse as one capsule making a macronodule thatis palpable.

Clinically the skin presents a padded appearance with presence ofpainful isolated macronodules or in conglomerate forming hard platesevidences itself. In this stage there is flabbiness.

Thermographically, the image presents one of Black Holes with extensivehypodermic zones that indicate that macronodules are presence.

In this EXAMPLE, the patient is administered the Temoporfin solution asfollows: In all sequences, the treatment consists 1 session only perarea to be treated, and, if necessary, it is repeated in 30 days. Ingeneral, it was observed that only 1 session followed by appropriatephysiotherapy, a complementary session (like ultrasound, lymph-drainage,isotonic and isometric electro-stimulation), was usually sufficient inmore than 80% of the patients. If it was necessary to repeat it, anevaluation is done after 30 days.

Other treatments included in this process might include the following,as examples:

-   Ultrasound; Lymphodrain and presotherapy; Thermotherapy; and    Isometric Electrotonotherapy.

Table 2 presents further information as to the stage of cellulite,concentration of mTHPC (Temoporfin), dose, surface area being treated;strength, power level and time of laser radiation application. TABLE 2The PDT's application TEMOPORFIN will follow the following parametersCELLULITIS M - THPC DOSE SURFACE LATENCY Watts TIME PDT I HARROW I II0.1 mg/ml 10 cc 600 cm2 (20 × 30) 30′ 2 W 2′ each 100 cm2 I HARROW III0.2 mg/ml 10 cc 600 cm2 (20 × 30) 30′ 2 W 2′ each 100 cm2 I HARROW IV0.2 mg/ml 10 cc 400 cm2 (20 × 20) 30′ 2.5 W   3′ each 100 cm2

These parameters are adjusted according to the patient's condition.

The following is a listing of the sequence of events in each session:

Accomplish a mapping with sectorial (See FIG. 9) thermographic imagesand the recording of this information as to each patient for referenceduring treatment;

Identify zones on the patient's body where there are areas of treatment;

Disinfect skin with alcohol;

Apply the Temoporfin solution in accordance with the treatment planestablished;

Apply ultrasound at the rate of 1 minute for each 100 cm² of surfacewhich further helps distribute the product within the cellulite tissue;

Wait for 30 minutes;

Apply the laser radiation from about 6.25 to 2.5 cm from the dermicsurface, with a spot of 3 cm, with a continuous mode, with a potency of2 watts, for 2 or 3 minutes on each 100 cm² depending on grade andapplied dose.

Apply a cold gel covered by plastic film to the areas of treatment;

Apply the cold gel film for 2 hours;

Allow the patient to remove the cold gel with a natural sponge appliedin circles after the treatment sessions.

The results of the treatment should be followed by thermography notingcold zones, micro-nodules and black holes. The patient's body should bedivided into sectors with the stage level noted for each. This isbeneficial for followup treatments and consultation. Pictures of a bodyare included noting the different sector numbers.

Sector 1: Gluteus

Sector 2: Posterior of thigh

Sectors 3 to the 8: Anterior of thigh

Because of the low dose concentration of Temoporfin, the cost should below so that it will be affordable.

Further, Lipofundin MCT 10% may be applied in the tissue with there iscellulites to improvement the Temoporfin's diffusion. Further,Lipofundin may be used to dilute the Temoporfin.

EXAMPLE 2

Temoporfin is a photosensitizer from a group that have affinity tophospholipids and cell membranes but are not soluble in triglycerides.

The appearance of cellulites, in the more severe stages, is a bubblingaffect having depressed areas and hill like areas. These areas mayrequire special treatment as follows:

-   1) For filling depressed areas:

a. the diluted Temoporfin (formulated in a liposome) is mixed 0.3 mg perml;

b. fat from liposuction is washed and mixed with the diluted temoporfinat a ratio 5 parts to 1 part;

c. an 18G needle is used to give the shot of this mixture in thedepressed area;

d. 30 minutes wait after shot;

e. PDT treatment; and

f. the treated area is washed.

-   2) For elevated zones or hills

a. a mesotherapy with Temoporfin (formulated in a liposome) having 0.3mg per ml was diluted.

b. inject this mixture into the area of treatment;

c. wait 30 minutes; and

d. PDT treatment.

In general the procedure is as follows: 1. analysis and marking off ofareas to be treated; 2. adding fluid to areas, after local anestheticapplied; 3. lasing of tissue within each area of treatment; 4. squeezeand suction of melted fat; and 5. application of ointments, etc., aftertreatments.

EXAMPLE 3

Steps for Patient Assessment and Treatment for Localized Cellulite:

-   1) Diagnostic: Clinical evaluation with anthropometric measurements,    weight and pictures complemented by the use of Thermograph charts to    confirm the clinical assessment of the cellulites stage (I, II, III    and IV)-   2) Treatment:

a. Temoporfin (formulated in a liposome) Mesotherapy deep injection:

1. 2 cc/100 cm² of area to be treated @ 0.05 mg/ml temoporfin dilution(Stage IV) only 1 injection used; and

2. 2 cc/100 cm² of area to be rated @0.025 mg/ml temoporfin dilution(Stage II and III) only 1 injection;

For example, on a buttock area of treatment, 6 or 8 cc of solution isused (@ 0.05 or 0.025 depending on the stage of the condition) Forserious conditions, liposuction is used to obtain some of the patient'sown fat which is cleaned and injected into the depressed areas;

b. Lymph-drainage/soft massage: This helps to distribute the drug withinthe area of treatment;

c. Wait 30 minutes;

d. Laser Illumination: area is divided into spots to cover the wholearea and a fluence of 0.8 J/cm2 is used on stage II & III (with 0.5 Wand time according to the area) or 1 J/cm2 on stage IV (with 0.75 W).

-   3) Post-Immediate:

a. Gel application; and

b. Light compression stockings.

-   4) Post @ 48 hrs: complementary sessions could be applied like:    lymph-drainage, press therapy, ultrasound, gels, etc.-   5) Follow-up: Assessment of results.

FIGS. 10 through 16 present examples of patients before and aftertreatment.

EXAMPLE 4

LED Based PDT for Cellulite Reduction

Before starting the treatment, patient clinical history is studied andphysical examination is performed. The cellulite is staged by clinicalimpression and by thermography.

Liposomal formulation of temoporfin diluted in 5% gluocuse solution isused. Diluted liposomal formulated temoporfin (1 part) is mixed withlipofundin (9 part) which helps better drug diffusion into thecellulite.

Pistol like device with trigger is used for injecting the drug into thetreatment site. Single shot using the device delivers 12 μl of liposomalformulated temoporfin; each injection site receives two such shots to adepth of 0.5 cm. Each injection site is separated from each other by 0.5cm approximately. Dose of the drug can be increased based on thecellulite stage which needs to be treated.

Illumination is performed using LED arrays (area of the array is 4*4 cm)with wavelength 652 nm, power density 180 mW/cm².

Treatment schedule: 4 LED treatments are performed in the patient. Thefirst starts 48 h after injection of the liposomal formulatedtemoporfin. The second, third and fourth are performed on 7, 14 and 21days after injection respectively.

Patient is examined at the end of 21 days and later follows ups showedgood improvement with better skin texture resulting in smoother skin.

For the sake of this invention and particularly for the claims, someprecursors of photosensitizers become photosensitizers by the naturalactivity of the animal injected with them. These are considered,therefore to be included within the general word, “photosensitizers”used in the claims and general specification, as was noted earlier.

Having described preferred embodiments of the invention with referenceto the accompanying drawing, it is to be understood that the inventionis not limited to the precise embodiments, and that various changes andmodifications may be effected therein by skilled in the art withoutdeparting from the scope or spirit of the invention as defined in theappended claims.

1. A method of reducing unwanted cellulite in selective areas of anorganism comprising the steps of: a. identifying said selective areas tobe treated; b. administering at least one photosensitizer to saidorganism; c. allowing a sufficient time for said photosensitizer toaccumulate in cellulite of the selective area of treatment; and d.selectively activating by light said photosensitizer in said selectiveareas to reduce/eliminate cellulite.
 2. The method of reducing unwantedcellulite according to claim 1, wherein said photosensitizer has anaffinity to phospholipids and cell membranes but is substantially notsoluble in triglycerides.
 3. The method of reducing unwanted celluliteaccording to claim 1 further including before step b, a step of mixingsaid photosensitizer into a mixture of cellular tissues from saidorganism.
 4. The method of reducing unwanted cellulite according toclaim 3 wherein said cellular tissues are selected from the groupconsisting of adipose cells, and collagen.
 5. The method of reducingunwanted cellulite according to claim 4 wherein a treatment fluidcomprising said photosensitizer and said cellular tissues mixed in aratio of about 1 part to 5 parts by volume.
 6. The method of reducingunwanted cellulite according to claim 4 wherein a volume of saidtreatment fluid administered to said selective area is adjustedaccording to whether said cellulite is in a depressed area of the skinor an elevated area on the skin.
 7. The method of reducing unwantedcellulite according to claim 1 wherein said administering step is bylocal application to the areas to be treated.
 8. The method of reducingunwanted cellulite according to claim 1 wherein said selectivelyactivating is by means of electromagnetic radiation, wherein saidelectromagnetic radiation includes a wavelength matching at least onepeak within said photosensitizer's absorption spectrum, and wherein saidelectromagnetic radiation is emitted by a light source selected from thegroup consisting of diode lasers, LEDs, and one or more lamps withfilters.
 9. The method of reducing unwanted cellulite according to claim8 wherein said radiation is applied by means of at least one opticalfiber.
 10. The method of reducing unwanted cellulite according to claim9 wherein said optical fiber has an output tip having a diffusing devicethereon.
 11. The method of reducing unwanted cellulite according toclaim 1 wherein said cellulite is adipose tissue accumulated in pocketsunder the skin of said organism forming depressed and elevated areas.12. The method of reducing unwanted cellulite according to claim 11wherein adipose tissue is white adipose tissue.
 13. The method ofreducing unwanted cellulite according to claim 1 wherein said celluliteare adipocytes.
 14. The method of reducing unwanted cellulite accordingto claim 1 wherein said identifying step comprises the use ofthermography to determine the stage of cellulites.
 15. A photosensitizermixture for treating cellulite tissue comprising: a hydrophobicphotosensitizer; and a carrier.
 16. The photosensitizer mixtureaccording to claim 15, wherein said photosensitizer has an affinity tophospholipids and cell membranes but is substantially not soluble intriglycerides.
 17. The photosensitizer mixture according to claim 16,wherein said photosensitizer is Temoporfin (mTHPC).
 18. Thephotosensitizer mixture according to claim 17 wherein in said Temoporfinis present within liposomes.
 19. The photosensitizer mixture accordingto claim 15 further comprising a material selected from the groupconsisting of Lipofundin, hyaluronic acid, and collagen/adiposepreviously removed by liposuction.
 20. The photosensitizer mixtureaccording to claim 19, wherein said material and said photosensitizerare present in a ratio of about 5 parts to 1 part by volume,respectively.